Registration Dossier
Registration Dossier
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EC number: 248-315-4 | CAS number: 27194-74-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 January 2016 - 09 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Lauric acid, monoester with propane-1,2-diol
- EC Number:
- 248-315-4
- EC Name:
- Lauric acid, monoester with propane-1,2-diol
- Cas Number:
- 27194-74-7
- Molecular formula:
- C15H30O3
- IUPAC Name:
- 1-hydroxypropan-2-yl dodecanoate; 2-hydroxypropyl dodecanoate
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material:1023R25811
- Expiration date of the lot/batch: 14 September 2019
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was used undiluted and freshly prepared as a solution in acetone/olive oil. The test item was formulated within 2 hours of being applied to the test system.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The test item at concentrations of 50%, 25% or 10% v/v in acetone/olive oil 4: 1.
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.75
- Test group / Remarks:
- 10% v/v in acetone/olive oil 4:1.
- Remarks on result:
- other: Negative
- Key result
- Parameter:
- SI
- Value:
- 0.87
- Test group / Remarks:
- 25% v/v in acetone/olive oil 4:1.
- Remarks on result:
- other: Negative
- Key result
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- 50% v/v in acetone/olive oil 4:1.
- Remarks on result:
- other: Negative
Applicant's summary and conclusion
- Interpretation of results:
- other: a non-sensitizer
- Conclusions:
- The test item was considered to be a non-sensitizer under the conditions of the test.
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